Decentralized Clinical Trials: Best Practices in Moving Toward a Patient-Centric Research Model
While the term can be used in different ways, decentralized clinical trials are fundamentally a movement of clinical studies away from medical institutions. In this model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be completed in a participant’s home or local community. This paper examines the nature of decentralized clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.
WCG IRB provides the highest quality ethical reviews of clinical research protocols and studies with more than 50 years’ experience and over 200 members on its AAHRPP-accredited boards. Since 2000, WCG IRB has also provided IBC administration and review services to nearly 800 institutions and evaluated more than 400 human gene transfer protocols. For more information, visit www.wcgirb.com.